Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- Conditions
- Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- Registration Number
- NCT04848753
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 663
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method To compare IRC-assessed events-free survival (EFS) in 2 arms From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
- Secondary Outcome Measures
Name Time Method 1-year OS rate from randomization to death from any cause at 1 year To compare 1-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy
3- year OS rate from randomization to death from any cause at 3 year To compare 3-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy
5- year OS rate from randomization to death from any cause at 5 year To compare 5-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy
pathologically complete remission (pCR) rate From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)
Investigator-assessed EFS according to RECIST v1.1 From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months To compare Investigator-assessed events-free survival (EFS) in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.
Overall survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months To compare Overall survival in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.
Trial Locations
- Locations (48)
The Firest Affiliated Hospital of bengbu Medical College
🇨🇳Bengbu, Anhui, China
Anhui provincial hospital
🇨🇳Hefei, Anhui, China
The Second Hospital of anhui Medical University
🇨🇳Hefei, Anhui, China
Jiangmen central Hospital
🇨🇳Jiangmen, Guangdong, China
Shenzhen people's hosptial
🇨🇳Shenzhen, Guangdong, China
The fourth hospital of hebei medical university
🇨🇳Shijiazhuang, Hebei, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Henan provincial pepples hospital
🇨🇳Zhengzhou, Henan, China
The first affilated hospital of zhengzhou university
🇨🇳Zhengzhou, Henan, China
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